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Preventing Health Damaging Behaviors in Male and Female Army Recruits

Preventing Health Damaging Behaviors in Male and Female Army Recruits

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01234103
Enrollment
933
Registered
2010-11-04
Start date
2010-09-30
Completion date
2013-06-30
Last updated
2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol and Other Substance Use Prevention, Intimate Partner Violence Prevention, Sexually Transmitted Infection (STI) Prevention, Sexual Risk Reduction, Unintended Pregnancy Prevention

Keywords

sexually transmitted infection, sexual risk, HIV, young adults, cognitive-behavioral intervention

Brief summary

Health damaging (risk) behaviors of young military personnel are reflections of health problems facing all young people in the U.S. Military life presents opportunities and challenges that may both protect against and place young troops at risk for health damaging behaviors. Challenges for maintaining a healthy armed force include high rates of sexually transmitted infections (STIs), unintended pregnancies (UIPs), misuse of alcohol and other substances. The common thread through these negative health outcomes is volitional behavior. Such behaviors do not only result in illness or injury, but also negatively impact performance of military duties and threaten military readiness. Despite military leadership in setting standards and policies regarding professional behavior and universal health care for preventing and eliminating such negative health outcomes, many health problems remain. Building on our previous military research, we will evaluate the effectiveness a cognitive-behavioral, skills-building intervention to prevent and reduce young troops' risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, and victimization due to IPV in male and female U.S. Army soldiers who are receiving Advance Individual Training (AIT) in Fort Jackson, SC.

Detailed description

The primary hypotheses to be tested in this research are as follows. AIT soldiers participating in the experimental STI/UIP prevention intervention will: (a) have increased knowledge about the risk factors for and prevention of STIs, UIPs, alcohol and other substances, and intimate partner violence (IPV); (b) be more highly motivated to change risk behaviors associated with STIs and UIPs; (c) have higher levels of skills to prevent risk behaviors associated with STIs and UIPs and skills; (d) engage in more health promoting behaviors and fewer risk behaviors associated with STIs and UIPs, and (e) have fewer STIs and UIPs post-intervention compared with AIT solders who participate in a comparable control intervention focused on increasing healthy eating, maintaining physical fitness, and preventing fitness-related injuries. The overall goal of this research is to evaluate the effectiveness a cognitive-behavioral skills-building intervention to prevent risk for and acquisition of STIs and UIPs and will seek to reduce a number of their associated risk factors including, alcohol misuse, other substance use, IPV in AIT soldiers. Specifically, we will evaluate whether AIT soldiers who participate in the experimental intervention entitled, Staying Safe and in Control: Increasing Knowledge and Building Skills to Prevent Sexually Transmitted Infections and Unintended Pregnancies will reduce their risk for and acquisition of STIs, UIPs and their associated sexual and substance use behaviors compared with AIT soldiers who undergo the control intervention entitled, Fit You: Practical Tools for Healthy Eating, Physical Fitness, and Injury Prevention. This intervention will focus primarily on promoting healthy eating, maintaining physical fitness, and preventing work-related and exercise injury.

Interventions

BEHAVIORALPreventing Helath Damaging Health Behaviors in Male and Female Army Recruits

Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors.

Sponsors

United States Department of Defense
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* All participants will be 18 years of age or older, will be fluent in English, and able to provide written, informed consent.

Exclusion criteria

* AIT soldiers under the age of 18 will be excluded since it will be difficult to obtain parental consent. We anticipate that this exclusion will be rare.

Design outcomes

Primary

MeasureTime frame
Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies6 to 9 months

Secondary

MeasureTime frame
Self-reported Behavioral Measures Related to STI/HIV Prevention6 to 9 months

Countries

United States

Participant flow

Participants by arm

ArmCount
Preventing Sexual Health Risks
The over goal is to prevent STIs, unintended pregnancies, and related behaviors including sexual risk, alcohol and other substance misuse Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors.
540
Improving Nutrition, Fitness and Injury Prevention
The goals are: (1) maintain and improve nutrition and physical fitness through healthier lifestyle and food choices; (2) reduce the risk of sports or physical training injuries and learning how to treat injuries; and (3) Learn to recognize stress and the steps you can take to reduce stress Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits: Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors.
393
Total933

Baseline characteristics

CharacteristicTotalPreventing Sexual Health RisksImproving Nutrition, Fitness and Injury Prevention
5 or more drinks of alcohol on 1 occassion-past 3 months
1 or more times/week
71 Participants44 Participants27 Participants
5 or more drinks of alcohol on 1 occassion-past 3 months
2-3 times/month
58 Participants26 Participants32 Participants
5 or more drinks of alcohol on 1 occassion-past 3 months
Missing
8 Participants4 Participants4 Participants
5 or more drinks of alcohol on 1 occassion-past 3 months
Never
62 Participants41 Participants21 Participants
5 or more drinks of alcohol on 1 occassion-past 3 months
No alcohol past 3 months
612 Participants366 Participants246 Participants
5 or more drinks of alcohol on 1 occassion-past 3 months
Once/month or less
122 Participants59 Participants63 Participants
Age, Continuous20.77 years
STANDARD_DEVIATION 3.121
20.77 years
STANDARD_DEVIATION 3.121
20.77 years
STANDARD_DEVIATION 3.124
Ethnicity (NIH/OMB)
Hispanic or Latino
151 Participants84 Participants67 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
780 Participants455 Participants325 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
2 Participants1 Participants1 Participants
Marital Status
Married
126 Participants76 Participants50 Participants
Marital Status
Missing
1 Participants1 Participants0 Participants
Marital Status
Separated/Divorce
9 Participants3 Participants6 Participants
Marital Status
Single/Never Married
797 Participants460 Participants337 Participants
Number of pregnancies (males and females)
1
136 Participants78 Participants58 Participants
Number of pregnancies (males and females)
2
60 Participants37 Participants23 Participants
Number of pregnancies (males and females)
3-5
39 Participants23 Participants16 Participants
Number of pregnancies (males and females)
Missing Data
8 Participants5 Participants3 Participants
Number of pregnancies (males and females)
None
690 Participants397 Participants293 Participants
Number of pregnancies unintended
1
118 Participants68 Participants50 Participants
Number of pregnancies unintended
2
40 Participants26 Participants14 Participants
Number of pregnancies unintended
3-5
18 Participants11 Participants7 Participants
Number of pregnancies unintended
Missing Data
12 Participants7 Participants5 Participants
Number of pregnancies unintended
None
745 Participants428 Participants317 Participants
Number of sex partners -ever9.36 sex partners
STANDARD_DEVIATION 20.967
10.09 sex partners
STANDARD_DEVIATION 26.3
8.39 sex partners
STANDARD_DEVIATION 10.272
Race/Ethnicity, Customized
African American/Black
198 Participants115 Participants83 Participants
Race/Ethnicity, Customized
American Indian
14 Participants7 Participants7 Participants
Race/Ethnicity, Customized
Asian/Pacific Islander
38 Participants28 Participants10 Participants
Race/Ethnicity, Customized
Caucasian/White
485 Participants279 Participants206 Participants
Race/Ethnicity, Customized
Hispanic/Latino/a
151 Participants84 Participants67 Participants
Race/Ethnicity, Customized
Missing Data
2 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Other/Mixed Race
45 Participants26 Participants19 Participants
Sex: Female, Male
Female
124 Participants68 Participants56 Participants
Sex: Female, Male
Male
809 Participants472 Participants337 Participants
Sexually transmitted infection diagnosed-ever
1
38 Participants23 Participants15 Participants
Sexually transmitted infection diagnosed-ever
2
13 Participants5 Participants8 Participants
Sexually transmitted infection diagnosed-ever
3
2 Participants0 Participants2 Participants
Sexually transmitted infection diagnosed-ever
Missing Data
5 Participants0 Participants5 Participants
Sexually transmitted infection diagnosed-ever
None
875 Participants512 Participants363 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 5400 / 393
other
Total, other adverse events
0 / 5400 / 393
serious
Total, serious adverse events
0 / 5400 / 393

Outcome results

Primary

Incidence of Sexually Transmitted Infections and the Self-reported Numbers of Unintended Pregnancies

Time frame: 6 to 9 months

Population: No data were collected from participants. Participants only attended intervention sessions.

Secondary

Self-reported Behavioral Measures Related to STI/HIV Prevention

Time frame: 6 to 9 months

Population: No data were collected from participants. Participants only attended intervention sessions.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026